11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
RETCAM 3 OPHTHALMIC IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTERLINK THREADED LOCK CANNULA
FDA 510(k)
FDA Class 2
·General Hospital
BD VACUTAINER® SST¿ II ADVANCE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 13, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 2, 2026
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·April 29, 2013
ISERT ASPHERIC INTRAOCULAR LENS
FDA Adverse Event
Malfunction
·HOYA SURGICAL OPTICS, INC.·Product code HQL·April 5, 2011
PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·July 23, 2008
BD VACUTAINER® SST¿ II ADVANCE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 25, 2024
BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injection site. It is screwed down over the Interlink¿ injection site and a blunt plastic cannula inside the housing enters the Interlink¿ injection site to provide a pathway for IV fluid administration.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·January 22, 2014
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012